Brain+ fully on track towards market entry and first sales in the United Kingdom in H2 2024

NEWS RELEASE 

Copenhagen, Denmark, 23 August 2024 – Brain+ A/S (Nasdaq First North: BRAINP)

• Brain+ is executing in full alignment with its Market Access plan for the CST-Assistant in the United Kingdom (UK), having met several milestones to date in 2024   

• Additional UK-related key milestones in view for Q3 include validation of the Clinical Evaluation Report for the CST-Assistant, final results from the Age UK usability study, and full UK Medical Device certification  

• Brain+ retains its expectations of the release of the CST-Assistant as a UK Medical-Device-Software before the end of Q3 and of the first UK sales before the end of 2024

Brain+ A/S (“Brain+” or “the Company”) informs of considerable progress to date in 2024 in full accordance with its Market Access plan for the CST-Assistant in the United Kingdom (UK). Based on this, the company confirms to be on track for commercial entry in September 2024 with expected first UK sales before the end of the year.  

The CST-Assistant is the most commercially mature product in Brain+’ pipeline of healthtech solutions for better dementia management. The CST-Assistant is an innovative software-based offering that enables more effective and scalable high-quality delivery of Cognitive Stimulation Therapy (CST), a clinically proven non-pharmaceutical therapy for people with mild- to moderate dementia.

Devika Wood, Chief Commercial Officer of Brain+ commented on the commercial outlook for the CST-Assistant in the UK: “I am really excited to start executing on the commercial part of our validated go-to-market plan within the UK, targeting the National Health Service (NHS) to scale the implementation of the CST-Assistant. Our primary focus is to secure contracts with NHS Trusts across Northern UK, particularly those with a proven commitment to Cognitive Stimulation Therapy (CST) and a forward-thinking approach to digital health. These Trusts are key players in dementia management and are eager to enhance their CST delivery capabilities. We are leveraging my UK healthcare contact network, and our initial outreach to Trusts and other key UK dementia stakeholders has been met with enthusiasm. Our first target is ‘evaluation track’ contracts, which fall within discretionary budgets to facilitate swift decision-making processes and rapid adoption. I feel very confident that we will have our first UK sales this year and be able to start scaling and see recurring revenue from 2025.”

Pathway to UK sales and proof-of-business  

In March 2024, Brain+ informed to have set a dedicated proof-of-business strategy for 2024-2025 focused on the UK, which had been evaluated to be the largest and most accessible European market for the company’s dementia healthtech solutions. Since then, the attractiveness of the UK market and the outlook for Brain+ to reach scalable sales and proof-of-business in 2025 have only been further solidified, as the Company has advanced on the strategy and been building its market presence in the UK market.

The Market Access approach for the CST-Assistant is based on a tried and validated commercial pathway for medical device software products in the UK, developed together with healthtech specialized UK commercial and regulatory advisors; Quiddity Health and 8foldGovernance.

With the recent hire of UK-based Devika Wood as the new Chief Commercial Officer, Brain+ has significantly upscaled its internal UK healthtech specific commercial competencies and resources. Building on Devika’s strong network and proven track record in achieving market adoption and commercial scaling of healthtech tools in the UK elderly care sector, UK sales operations are now being established with defined metrics and sales targets to drive Brain+’ commercialization journey.

The first step in the commercial plan for the CST-Assistant in the UK is to target so-called ‘evaluation track’ contracts with NHS Trusts, typically ranging from £10,000 - £30,000 in size. The NHS is responsible for most of the UK's dementia management, and ‘evaluation contracts’ are designed for early adoption of new healthtech solutions into the UK for a relatively quick transition into recurring use and multi-year agreements. Brain+’ commercial scaling approach is thereafter to secure contracts with individual NHS Trusts while simultaneously working to build additional clinical evidence to secure regional reimbursement and larger multi-Trust contracts at the Integrated Care Systems (ICS) level. Such ICS contracts can be valued at £500,000 or more.

UK-focused milestones met to date in 2024

• UK Market Access and Commercial Scaling plan in place

Brain+ has developed and is executing an operational plan for UK market access and commercial scaling. Activities are focused on two tracks: 1) obtain UK certification of the CST-Assistant as a Medical-Device-Software for dementia management and 2) build commercial presence and target select NHS Trusts. The defined target is to sign the first NHS-based commercial contract before the end of 2024 while shaping the CST-Assistant offering as a full clinical CST service solution to meet market needs for scaling. In parallel, market research into the highly valuable at-home dementia care market (estimated value of £55 billion) will inform Brain+’ pipeline in preparation for the next product releases. 

• Submitted application for the CST-Assistant to be included on the G-Cloud-based NHS procurement platform

Getting the CST-Assistant on the NHS procurement platform will facilitate easier access to sales with NHS Trusts and include a listed NHS price point for the product. So far, no critical comments have been received, and a final response on the application is expected by the end of October.

• First UK usability study of the CST-Assistant completed in partnership with Age UK

Two Age UK sites in the Manchester area have just completed a full CST program (14 group sessions) using the CST-Assistant. Initial study feedback indicates user satisfaction and time savings. Full study data are being processed and final consolidated results are expected to be available soon.

• UK subsidiary, Brain+ UK Ltd, established to enable sales and open access to funding

Having a UK-based subsidiary facilitates NHS contracting and opens access to both relevant UK grant options and local investment networks to help fund the scaling of UK commercial operations and product development.

• In-house commercial competencies secured with the hire of UK-based Chief Commercial Officer  

Devika Wood has a strong UK healthtech commercialization track record and will be instrumental in driving Brain+ commercial operations.

• Development of the UK-version of the CST-Assistant advanced to the QA phase

Content and feature development is in the final stages and the product has entered the Quality Assurance (QA) stage, including Cyber Essentials Certification and Digital Technology Assessment Criteria (DTAC) compliance. All are important elements for approval and subsequent release of the CST-Assistant as a Medical-Device-Software.

• Clinical Evaluation Report for the CST-Assistant finalized

The Clinical Evaluation Report (CER) for the CST-Assistant has been finalized and is currently in review for compliance and validation.

Upcoming UK Market Access and commercial milestones for the rest of 2024

• August/September – Validation of compliance of the CST-Assistant CER

The Clinical Evaluation Report (CER) documents the clinical relevance of the CST-Assistant for dementia management. Validation of compliance of the CER with UK Medical Device Regulations is a critical component for certification of the product as a Medical-Device-Software.

• September – Final results of the Age UK usability study

Supportive results will help document product-market fit indications and cost-effectiveness of the CST-Assistant in the UK care pathway.

• September – UK certification of the CST-Assistant as a Medical-Device-Software  

Product certification against UK Medical Device Regulation is perceived by the NHS as a key stamp of quality and differentiation. It will validate the clinical benefits and the software quality of the CST-Assistant for CST to facilitate higher pricing and reimbursement.

• September – Commercial release of the CST-Assistant

Final commercial release to follow regulatory certification will open for product demonstrations, direct sales outreach to NHS trusts, and the first sales contracts.

• November/December – Close first UK sales contracts

Close the first £10,000-£30,000 sized ‘evaluation track’ type contracts with NHS Trust.

Contact Information

CEO and Co-founder, Kim Baden-Kristensen, + 45 31 39 33 17 (SMS), [email protected]

Chief Commercial Officer, Devika Wood, [email protected] 

Brain+ mission: Become the preferred provider of certified healthtech solutions for better dementia management, servicing one million people affected by dementia by 2030.